ASCO GU 2022: HRQoL in Previously Untreated Patients With Advanced Renal Cell Carcinoma: CheckMate 9ER Updated Results

( The 2022 GU ASCO Annual meeting included a renal cell carcinoma (RCC) session highlighting work from Dr. David Cella and investigators presenting results assessing HRQoL in previously untreated patients with advanced renal cell carcinoma in the CheckMate 9ER trial. In CheckMate 9ER,1 patients with advanced RCC were randomized 1:1 to nivolumab 240 mg IV Q2W + cabozantinib 40 mg PO QD n = 323) or sunitinib 50 mg PO (4 weeks of 6-week cycles; n = 328). As reported previously, at a median follow-up of 18.1 months, nivolumab + cabozantinib led to superior progression-free and overall survival and more favorable HRQoL than sunitinib. At the 2022 GU ASCO meeting, Dr. Cella reported results of HRQoL analyses for 32.9-months follow-up.

 Disease-related symptoms were evaluated using the FKSI-19 instrument and HRQoL with the EQ-5D-3L visual analogue scale (VAS). Change from baseline was assessed using mixed-model repeated measures, adjusting for baseline scores and stratification factors, and included all common time points (at baseline and every 6 weeks) through week 151. Time to deterioration analysis was conducted for first (TFD), confirmed (TCD) and definitive (TDD) deterioration events using Kaplan-Meier estimates and Cox proportional hazards models. Bother with treatment side effects (item GP5 in FKSI-19) was assessed using a generalized estimating equations model with response dichotomized as minimal bother (not at all or a little bit) vs notable bother (somewhat, quite a bit, and very much). 

 A total of 651 patients were randomized to nivolumab + cabozantinib (n=323) or sunitinib (n=328), with PRO completion rates in both treatment arms >90%. Group mean scores over time showed that HRQoL was maintained or improved from baseline with nivolumab + cabozantinib while reductions were observed with sunitinib. Overall changes from baseline though week 151 favored nivolumab + cabozantinib with nominal significant differences between treatments observed for all scores except functional well-being:




Similarly, decreased risk of deterioration was observed with nivolumab + cabozantinib vs sunitinib for all scores except functional well-being, irrespective of the deterioration definition used (TFD, TCD, TDD):




The Kaplan-Meir plot for TTD in FKSI-19 DRS favored nivolumab + cabozantinib (HR 0.53, 95% CI 0.37-0.75):




Patients in nivolumab + cabozantinib arm were 48% (OR 0.52, 95% CI, 0.35-0.77) less likely to be notably bothered by side effects than patients in sunitinib arm.


Dr. Cella concluded his presentation of assessing HRQoL in previously untreated patients with advanced renal cell carcinoma in the CheckMate 9ER trial with the following take-home messages:

  • Patients continued to report improved HRQoL with nivolumab + cabozantinib compared to sunitinib
  • Treatment with nivolumab + cabozantinib reduced the risk of meaningful deterioration in HRQoL scores, regardless of the definition of deterioration and showed a decreased risk of being bothered by treatment side effects in contrast to sunitinib
  • These results suggest that the superior efficacy of nivolumab + cabozantinib over sunitinib with the additional benefit of improved HRQoL is maintained with longer follow-up

Presented By: David Cella, PhD, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL

Co-Authors: Robert J. Motzer, Steven I. Blum, Flavia Ejzykowicz, Melissa Hamilton, Joel Wallace, Joshua Zhang, Burcin Simsek, Cristina Ivanescu, Toni Choueiri

Affiliations: Memorial Sloan Kettering Cancer Center, New York, NY, Bristol Myers Squibb, Princeton, NJ, Exelixis, Alameda, CA, IQVIA, Amsterdam, Netherlands, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School


Written By: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022


  1. Choueiri TK, Powles T, Burotto M, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021 Mar 4;384(9):829-841.